US6465191B1ExpiredUtilityPatentIndex 65

Process for separating and/or detecting and/or quantifying (an) infectious compound(s) and support for implementing the process

Assignee: INST RECH DEVELOPPEMENT IRDPriority: Aug 1, 1994Filed: Jan 31, 1997Granted: Oct 15, 2002

Est. expiryAug 1, 2014(expired)· nominal 20-yr term from priority

Inventors:STEFAS ELIE RUCHETON MARCELL GRAAFLAND HUBERT VEAS FRANCISCO

G01N 33/56988G01N 33/5761G01N 33/56983Y02A50/30G01N 33/569

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Claims

Abstract

Method for separating and/or screening and/or quantifying one or more infectious compounds (IC) in a biological material, characterised in that a beta2GPLIC complex, chosen from the group comprising a) (beta2GPI)n/IC complexes and b) (beta2GPI)r/nVIC (non viral IC) complexes, is separated and/or screened and/or quantified.

Claims

exact text as granted — not AI-modified

What is claimed is:

1. A method for detecting the presence of an infectious compound in a biological sample which comprises:
detecting the presence of naturally occurring complexes of an infectious compound and
β2-glycoprotein I (β2GPI) in the sample;
wherein said infectious compound is present in an infected organism, and not present in a non-infected organism.

2. A method for detecting the amount of an infectious compound in a biological sample which comprises:
detecting the presence of naturally occurring complexes of an infectious compound and β2-glycoprotein I (β2GPI) in the sample; and
determining the amount of the infectious compound in the sample based on the level of complex detected;
wherein no exogenous β2-GPI is added to the sample, and wherein said infectious compound is present in an infected organism, and not present in a non-infected organism.

3. The method according to claim 1 wherein at least one viral particle or viral protein is the infectious compound.

4. The method according to claim 2 wherein at least one viral particle or viral protein is the infectious compound.

5. The method according to claim 1 wherein at least one non-viral particle or non-viral protein is the infectious compound.

6. The method according to claim 2 wherein at least one non-viral particle or non-viral protein is the infectious compound.

7. The method according to claim 1 wherein at least one component of a bacterium, a parasite, a mycoplasma or an abnormal animal cell is the infectious compound, and binds said β2 glycoprotein I.

8. The method according to claim 2 wherein at least one component of a bacterium, a parasite, a mycoplasma or an abnormal animal cell is the infectious compound, and binds said β2 glycoprotein I.

9. The method according to claim 1 wherein the complex is attached to a support through said β2GPI, and the infectious compound in the attached complex is detected.

10. The method according to claim 2 wherein the complex is attached to a support through said β2GPI, and the infectious compound in the attached complex is detected.

11. The method according to claim 1 wherein the complex is attached to a support through the infectious compound, said method further comprising the step of separating the sample from the support under conditions wherein the complex remains attached to the support, and the β2GPI in the attached complex is detected.

12. The method according to claim 2 wherein the complex is attached to a support through the infectious compound, said method further comprising the step of separating the sample from the support under conditions wherein the complex remains attached to the support, and the β2GPI in the attached complex is detected.

13. The method according to claim 1 wherein the complex is attached to a support by means of an attachment substance, wherein the attachment substance binds the complex through either the infectious compound or the β2GPI, and wherein said method further comprises the step of separating the sample from the support under conditions wherein the complex remains attached to the support, and either the β2GPI or the infectious compound in the attached complex is detected, whichever is not bound to the attachment substance.

14. The method according to claim 2 wherein the complex is attached to a support by means of an attachment substance, wherein the attachment substance binds the complex through either the infectious compound or the β2GPI, and wherein said method further comprises the step of separating the sample from the support under conditions wherein the complex remains attached to the support, and either the β2GPI or the infectious compound in the attached complex is detected, whichever is not bound to the attachment substance.

15. The method of any one of claims 9 - 14 wherein said support is a solid support selected from the group consisting of a membrane, a microtitration plate and a microscope slide.

16. The method of any one of claims 9 - 14 wherein the attachment substance is a protein.

17. The method of claim 16 wherein the protein is an antibody which specifically binds to said β2GPI.

18. The method of claim 16 wherein said protein is HIV 2 p26ROD which specifically binds to said β2GPI.

19. The method of claim 3 wherein said at least one viral particle or viral protein is a viral particle or viral protein selected from the group consisting of human immunodeficiency virus 1, human immunodeficiency virus 2, hepatitis B virus and herpes simplex virus.

20. The method of claim 4 wherein said at least one viral particle or viral protein is a viral particle or viral protein selected from the group consisting of human immunodeficiency virus 1, human immunodeficiency virus 2, hepatitis B virus and herpes simplex virus.

21. A method for detecting the presence of an infectious compound of a non-viral infectious agent in a sample of biological material, comprising
adding exogenous β2-glycoprotein I (β2GPI) to the sample, under conditions whereby any infectious compound of a non-viral infectious agent present in the sample forms a complex with the added β2GPI; and
detecting the presence of the complex.

22. A method for detecting the amount of an infectious compound of a non-viral infectious agent in a sample of biological material, comprising
adding exogenous β2-glycoprotein I (β2GPI) to the sample, under conditions whereby any infectious compound of a non-viral infectious agent present in the sample forms a complex with the added β2GPI;
detecting the presence of the complex; and
determining the amount of the infectious compound present in the sample based on the level of complex detected.

23. The method according to claim 21 wherein at least one component of a bacterium, a parasite, a mycoplasma or an abnormal animal cell is the infectious compound, and binds said β2 glycoprotein I.

24. The method according to claim 22 wherein at least one component of a bacterium, a parasite, a mycoplasma or an abnormal animal cell is the infectious compound, and binds said β2 glycoprotein I.

25. The method according to claim 21 wherein the complex is attached to a support through said β2GPI, and the infectious compound in the attached complex is detected.

26. The method according to claim 22 wherein the complex is attached to a support through said β2GPI, and the infectious compound in the attached complex is detected.

27. The method according to claim 21 wherein the complex is attached to a support through the infectious compound, said method further comprising the step of separating the sample from the support under conditions wherein the complex remains attached to the support, and the β2GPI in the attached complex is detected.

28. The method according to claim 22 wherein the complex is attached to a support through the infectious compound, said method further comprising the step of separating the sample from the support under conditions wherein the complex remains attached to the support, and the β2GPI in the attached complex is detected.

29. The method according to claim 21 wherein the complex is attached to a support by means of an attachment substance, wherein the attachment substance binds the complex through either the infectious compound or the β2GPI, and wherein said method further comprises the step of separating the sample from the support under conditions wherein the complex remains attached to the support, and either the β2GPI or the infectious compound in the attached complex is detected, whichever is not bound to the attachment substance.

30. The method according to claim 22 wherein the complex is attached to a support by means of an attachment substance, wherein the attachment substance binds the complex through either the infectious compound or the β2GPI, and wherein said method further comprises the step of separating the sample from the support under conditions wherein the complex remains attached to the support, and either the β2GPI or the infectious compound in the attached complex is detected, whichever is not bound to the attachment substance.

31. The method of any one of claims 25 - 30 wherein said support is a solid support selected from the group consisting of a membrane, a microtitration plate and a microscope slide.

32. The method of any one of claims 29 - 30 wherein the attachment substance is a protein.

33. The method of claim 32 wherein the protein is an antibody which specifically binds to said β2GPI.

34. The method of claim 33 wherein said protein is HIV 2 p26ROD which specifically binds to said β2GPI.

35. The method according to claim 21 , wherein said β2-glycoprotein I is β2′GPI obtained by eluting an affinity chromatography column from a purification process of albumin from blood plasma, which has a molecular weight of 50,000±3000 daltons.

36. The method according to claim 22 , wherein said β2-glycoprotein I is β2′GPI obtained by eluting an affinity chromatography column from a purification process of albumin from blood plasma, which has a molecular weight of 50,000±3000 daltons.

37. The method according to claim 21 , wherein at least one of said β2-glycoprotein I and said infectious compound is obtained from an animal or is produced by genetic or chemical engineering.

38. The method according to claim 22 , wherein at least one of said β2-glycoprotein I and said infectious compound is obtained from an animal or is produced by genetic or chemical engineering.

39. A method for detecting the presence of an infectious compound of a non-viral infectious agent in a sample of biological material, comprising
adding exogenous β2-glycoprotein I (β2GPI) to the sample, under conditions whereby any infectious compound of a non-viral infectious agent present in the sample forms a complex with the added β2GPI; and
detecting the presence of the complex formed between the infectious compound of a non-viral infectious agent and the added β2GPI.

40. A method for detecting the amount of an infectious compound of a non-viral infectious agent in a sample of biological material, comprising
adding exogenous β2-glycoprotein I (β2GPI) to the sample, under conditions whereby any infectious compound of a non-viral infectious agent present in the sample forms a complex with the added β2GPI;
detecting the presence of the complex formed between the infectious compound of a non-viral infectious agent and the added β2GPI; and
determining the amount of the infectious compound present in the sample based on the level of complex detected.

41. The method according to claim 39 wherein the complex is attached to a support through said β2GPI, and the infectious compound in the attached complex is detected.

42. The method according to claim 40 wherein the complex is attached to a support through said β2GPI, and the infectious compound in the attached complex is detected.

43. The method according to claim 39 wherein the complex is attached to a support through the infectious compound, said method further comprising the step of separating the sample from the support under conditions wherein the complex remains attached to the support, and the β2GPI in the attached complex is detected.

44. The method according to claim 40 wherein the complex is attached to a support through the infectious compound, said method further comprising the step of separating the sample from the support under conditions wherein the complex remains attached to the support, and the β2GPI in the attached complex is detected.

45. The method according to claim 39 wherein the complex is attached to a support by means of an attachment substance, wherein the attachment substance binds the complex through either the infectious compound or the β2GPI, and wherein said method further comprises the step of separating the sample from the support under conditions wherein the complex remains attached to the support, and either the β2GPI or the infectious compound in the attached complex is detected, whichever is not bound to the attachment substance.

46. The method according to claim 40 wherein the complex is attached to a support by means of an attachment substance, wherein the attachment substance binds the complex through either the infectious compound or the β2GPI, and wherein said method further comprises the step of separating the sample from the support under conditions wherein the complex remains attached to the support, and either the β2GPI or the infectious compound in the attached complex is detected, whichever is not bound to the attachment substance.

47. The method of any one of claims 41 - 46 wherein said support is a solid support selected from the group consisting of a membrane, a microtitration plate and a microscope slide.

48. The method of any one of clams 45 - 46 wherein the attachment substance is a protein.

49. The method of claim 48 wherein the protein is an antibody which specifically binds to said β2GPI.

50. The method of claim 49 wherein said protein is HIV 2 p26ROD which specifically binds to said β2GPI.

51. The method according to claim 39 , wherein said β2-glycoprotein I is β2′GPI obtained by eluting an affinity chromatography column from a purification process of albumin from blood plasma, which has a molecular weight of 50,000±3000 daltons.

52. The method according to claim 40 , wherein said β2-glycoprotein I is β2′GPI obtained by eluting an affinity chromatography column from a purification process of albumin from blood plasma, which has a molecular weight of 50,000±3000 daltons.

53. The method according to claim 39 , wherein at least one of said β2-glycoprotein I and said infectious compound is obtained from an animal or is produced by genetic or chemical engineering.

54. The method according to claim 40 , wherein at least one of said β2-glycoprotein I and said infectious compound is obtained from an animal or is produced by genetic or chemical engineering.

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